降纤酶治疗急性脑梗死Ⅱ期临床研究

目的探讨降纤酶治疗急性脑梗死的有效性和安全性,并进行客观评价.方法按照全国脑防办<降纤酶治疗急性脑梗死第二阶段临床再评价研究>实施方案,采用前瞻性、随机、双盲、安慰剂对照的临床研究方法,将49例符合标准的急性脑梗死患者随机分为降纤酶组和对照组.评定指标包括脑卒中的临床神经功能缺损程度评分、Barthel指数、血浆纤维蛋白原水平、副作用.结果治疗组23例,终止治疗5例,其中1例自动退出试验、2例消化道出血、1例出现皮肤大片淤斑、1例突然死亡;对照组26例,终止1例,为自动退出试验.(1)治疗组应用降纤酶后血浆纤维蛋白原水平降低与对照组比较,差异非常显著(P＜0.001).尤其用药第6天最显著;(2)治疗后14天临床神经功能缺损评分减少优于对照组,有显著性差异(P＜0.05),但第14天、3个月时Barthel指数评分并无显著差异;(3)治疗组应用降纤酶后有1例病情加重,而对照组中有4例病情加重;(4)治疗组中有2例出现上消化道出血,1例皮肤大片淤斑,而对照组无上述情况.结论降纤酶降低血浆纤维蛋白原的作用确切,对减少神经功能缺损评分疗效显著,具有抑制急性脑梗死病情进展的作用,本组无1例并发颅内出血,但有消化道出血及皮下出血,有增加出血危险性的可能.

Clinical Study of the 2nd Stage on the Defibrase in the Treatment of Acute Cerebral Infarction

Objective To assess the safety and efficacy of defibrase in the treatment of acute cerebral infarction by a clinical study. Methods 49 cases of acute infarction were divided into trial group (23 cases) and control group (26 cases) by randomized double blind strategy.The end points included Clinically Neurological Deficit Scale of Stroke,Barthel Index,the level of plasma fibrinogen(FIB) and adverse reaction. Results (1)The level of plasma FIB in defibrase group was remarkably declined after treatment as compared with the control group(P<0.001),especially in the sixth day of onset.(2)Clinically Neurological Deficits Scale of Stroke at 14th days was decreased significantly after treatment as compared with the control group(P<0.05). But there was no statistically significant difference, at the Barthel Index at 14th days and 21 days between two groups.(3)One patient's condition got worse in the trial group,but so did 4 patients in the control group.(4)Upper gastrointestinal hemorrhage occurred in 2 patients,and skin ecchymosis occurred in 1 patient in the trial group.There were no such situation in the control group. Conclusion The study showed that defibrase appears effective in degrading plasma FIB and Clinically Neurological Deficits Scale of Stroke.However,there also may be an elevated risk of hemorrhage.